Engineering Support Specialist
101 Orchard Ridge Dr North Potomac, MD 20878 US
Job Description
Target Pay Rate: 30-47.85/hr **salary will be commensurate with experience
Job Description:
The candidate will work with combination products and the associated life-cycle maintenance activities. This includes Design Transfers, Periodic Risk Review Reports, Design History File (DHF) Remediation and commercial manufacturing support. Activities may include:
- Performing gap assessments on existing DHFs against SOPs and standards
- Updating relevant documents within the DHF
- Performing impact assessments for design changes
- Managing Change Controls and driving the implementation of the necessary activities for the change
- Analyzing complaints and compiling relevant data for the annual risk review
- Working with different functions such as; device development, device quality, drug product, packaging, and human factors
This position is located in the Drug Product Combination Product Global Technical Operations group located in Gaithersburg, MD. Working remotely is possible.
Position Qualifications (Preferred):
- Technical background in engineering (Bsc.)
- Experience with combination product LCM and design controls
- Experience in biotech/pharmaceutical or medical device company
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